Efficacy and Safety Study of FP MDPI Compared With FS MDPI in Adolescent and Adult Patients With Persistent Asthma

Exclusion Criteria

• •1. A history of a life-threatening asthma exacerbation (an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, or hypoxic seizures).
• •2. The patient is pregnant or lactating, or plans to become pregnant during the study period or for 30 days after the study.
• •3. The patient has participated as a randomized patient in any investigational drug study within 30 days of the SV.
• •4. The patient has previously participated as a randomized patient in a study of Fp MDPI or FS MDPI.
• •5. The patient has a known hypersensitivity to any corticosteroid, salmeterol, or any of the excipients in the study drug or rescue medication formulation (ie, lactose).
• •6. The patient has been treated with any known strong cytochrome P450 (CYP) 3A4 inhibitors (eg, azole antifungals, ritonavir, or clarithromycin) within 30 days before the SV.
• •7. The patient has been treated with any of the prohibited medications during the prescribed (per protocol) washout periods before the SV.
• •8. The patient currently smokes or has a smoking history of 10 pack years or more (a pack year is defined as smoking 1 pack of cigarettes/day for 1 year). The patient must not have used tobacco products within the past year (eg, cigarettes, cigars, chewing tobacco, or pipe tobacco).
• •9. The patient has a culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that has not resolved at least 2 weeks before the SV.
• •10. The patient has a history of alcohol or drug abuse within 2 years preceding the SV.
• •11. The patient has had an asthma exacerbation requiring systemic corticosteroids within 30 days before the SV, or has had any hospitalization for asthma within 2 months before the SV.
• •12. Initiation or dose escalation of immunotherapy (administered by any route) is planned during the study period. However, patients on stable immunotherapy may be considered for inclusion.
• •13. The patient has used immunosuppressive medications within 4 weeks before the SV.
• •14. The patient is unable to tolerate or unwilling to comply with the appropriate washout periods and withholding of all applicable medications.
• •15. The patient has untreated oral candidiasis at the SV. Patients with clinical visual evidence of oral candidiasis who agree to receive treatment and comply with appropriate medical monitoring may enter the study.
• •16. The patient has a history of a positive test for human immunodeficiency virus (HIV), active hepatitis B virus, or hepatitis C infection.
• •17. The patient is either an employee or an immediate relative of an employee of the clinical investigational center.
• •18. A member of the patient's household is participating in the study at the same time. However, after the enrolled patient completes or discontinues participation in the study, another patient from the same household may be screened.
• •19. The patient has a disease/condition that in the medical judgment of the investigator would put the safety of the patient at risk through participation or that could affect the efficacy or safety analysis if the disease/condition worsened during the study.
• •* other criteria may apply, please contact the investigator for more information